Spruce Biosciences said it completed two Type B meetings with the U.S. FDA supporting its planned biologics license application (BLA) for tralesinidase alfa enzyme replacement therapy (TA-ERT) for Sanfilippo syndrome type B (MPS IIIB). The FDA indicated that integrated data from interventional clinical studies and available natural history data may be used to support cerebrospinal fluid heparan sulfate non-reducing end (CSF HS-NRE) as a reasonably likely surrogate endpoint for a potential accelerated approval pathway, and the parties discussed initiating a required confirmatory study during BLA review. The company said the BLA submission timing has shifted to the fourth quarter of 2026 to meet drug product process performance qualification batch requirements; no new clinical results presentation was announced.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Spruce Biosciences Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 202602180700BIZWIRE_USPR_____20260218_BW269143) on February 18, 2026, and is solely responsible for the information contained therein.